MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122505
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a major aortopulmonary collateral arteries (mpca) coil embolization procedure, there was resistance between a microcatheter (prowler select plus, lpes) and a 2.5mm x 5cm galaxy g3 xsft coil (glx122505, l13785).It was not able to come out from the microcatheter.It was replaced with another coil and the procedure completed.There was no patient injury reported.This was the first coil being used.The lesion was the collateral circulation coming from the right internal mammary artery.Additional information received indicated that the same prowler select plus mc was used successfully with the replaced coil.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was found kinked.One non-sterile unit galaxy g3 xsft 2.5mm x 5cm was received inside of a pouch.The received device was visually inspected, the dpu was found with several kinks.Then a microscopic inspection was performed, the embolic coil was found stuck inside the introducer with a kinked condition.No other damages were observed.Also, the marker band was found at 40.1cm from distal end and it was found within specification.A manufacturing record evaluation was performed for the finished device l13785 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs)- impeded in microcatheter with no loss of cerebral target position¿ could not be evaluated because the embolic coil was found kinked, still inside of the introducer and it was unable to move.However, the kinked condition noted on the embolic coil may have contributed to an impediment and due to this we can confirm the complaint.The kinked condition appears to have been caused by excessive force and handling being applied to the device, however, none of those can be conclusively determined.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during a major aortopulmonary collateral arteries (mpca) coil embolization procedure, there was resistance between a microcatheter (prowler select plus, lpes) and a 2.5mm x 5cm galaxy g3 xsft coil (glx122505, l13785).It was not able to come out from the microcatheter.It was replaced with another coil and the procedure completed.There was no patient injury reported.This was the first coil being used.The lesion was the collateral circulation coming from the right internal mammary artery.The same prowler select plus mc was used successfully with the replaced coil.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was found kinked.

• Brand Name: GALAXY G3 XSFT 2.5MM X 5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9676008
• Report Number: 3008114965-2020-00022
• Device Sequence Number: 2664333
• Product Code: KRD
• UDI-Device Identifier: 10886704077626
• UDI-Public: 10886704077626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: GLX122505
• Device Catalogue Number: GLX122505
• Device Lot Number: L13785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1